gastric cancer
Conditions
Interventions
Case series:toripalimab combined with first-line chemotherapy
Sponsors
Huashan hospital , Fudan university
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. pathologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction, with no her-2 over expression; 2. without chemotherapy, targeted drugs, pd-1 monoclonal antibody, ctla-4 monoclonal antibody and other anti-tumor drugs (except for recurrence or metastasis more than 6 months after the end of postoperative adjuvant therapy); 3. Aged 18-80 years old; 4. survival is expected to be more than 3 months; 5. PS 0 or 1; 6. at least one evaluable lesion; 7. no obvious pulmonary, heart, liver and kidney dysfunction; 8. women of child-bearing age must undergo a pregnancy test (serum) within 7 days prior to enrollment and the result is negative, and be willing to use appropriate methods of contraception during the trial and within 8 weeks after the last dose of the test drug; 9. participate in the test voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. have been diagnosed with other malignant tumors; 2. adenocarcinoma of the stomach or gastroesophageal junction accompanied by overexpression of her-2; 3. metastasis or recurrence occurred during adjuvant chemotherapy after radical surgery or within 6 months after the end of chemotherapy; 4. those who have been treated with currently recognized effective anti-tumor drugs; 5. estimated intolerance to DOX (docetaxel, oxaliplatin, capecitabine) chemotherapy; 6. the expected survival period is less than 3 months; 7. abnormal blood routine, liver and kidney electrolyte, immune-related indicators, thyroid routine, sex hormone and cortisol hormone; 8. patients with cardiac insufficiency, personal history of cerebral infarction, personal history of acute myocardial infarction, and poor blood glucose control of diabetes; 9. immune-related pneumonia, enteritis, hepatitis, conjunctivitis, dermatomyositis, systemic lupus erythematosus, allergic dermatitis and other rheumatic immune-related diseases; 10. pregnant or lactating women, or patients who are fertile but do not take contraceptive measures; 11. uncontrolled infection; 12. other conditions considered inappropriate by the investigator to participate in the study (such as those who may be allergic to DOX chemotherapy and triplegmab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactXiao-Hua Liang
Huashan Hospital, Fudan University
Outcome results
None listed